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Karl Storz Endoscopy, El Segundo, CA – FDA Inspections

Inspection records and compliance data for Karl Storz Endoscopy in El Segundo, California. 4 FDA inspections on record, 1 Form 483, last inspected September 12, 2024.

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Company Profile

This profile covers Karl Storz Endoscopy based in El Segundo, California, United States.

FDA Inspection History

FDA inspections
4
OAI
0
VAI
1
NAI
3
Form 483s
1
Warning letters
0

First inspected May 6, 2014. Last inspected September 12, 2024.

Most cited issue areas

  • Individual Report of Malfunction1 inspection
  • Lack of or inadequate complaint procedures1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
September 12, 2024VAIMedical Devices & Rad Health · Compliance: Medical Devices1249138
August 20, 2020NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1128796
April 16, 2018NAIMedical Devices & Rad Health · Compliance: Devices1054311
May 6, 2014NAIMedical Devices & Rad Health · Compliance: Devices868536
FDA documents

EIRs (2)

  • EIRs · August 20, 2020
  • EIRs · April 16, 2018
People (3)
Yvonne Fernandez
Person
Sken Huang
Person
Serkan Sezer
Person
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Company Information

Name

Karl Storz Endoscopy

FEI Number

3007475226

Address

2151 E Grand Ave, El Segundo, California 90245, United States

Country

United States

ID: cd323f8a-143e-4220-9614-41010b67c857

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